[Congressional Record Volume 166, Number 195 (Tuesday, November 17, 2020)]
[House]
[Pages H5805-H5807]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
MAKING OBJECTIVE DRUG EVIDENCE REVISIONS FOR NEW LABELING ACT OF 2020
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 5668) to amend the Federal Food, Drug, and Cosmetic Act to
modernize the labeling of certain generic drugs, and for other
purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 5668
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Making Objective Drug
Evidence Revisions for New Labeling Act of 2020'' or the
``MODERN Labeling Act of 2020''.
SEC. 2. MODERNIZING THE LABELING OF CERTAIN GENERIC DRUGS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section
503C the following:
``SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN DRUGS.
``(a) Definitions.--For purposes of this section:
``(1) The term `covered drug' means a drug approved under
section 505(c)--
``(A) for which there are no unexpired patents included in
the list under section 505(j)(7) and no unexpired period of
exclusivity;
``(B) for which the approval of the application has been
withdrawn for reasons other than safety or effectiveness; and
``(C) for which--
``(i)(I) there is new scientific evidence available
pertaining to the existing conditions of use that is not
reflected in the labeling;
``(II) the approved labeling does not reflect current legal
and regulatory requirements for content or format; or
``(III) there is a relevant accepted use in clinical
practice that is not reflected in the approved labeling; and
``(ii) updating the labeling would benefit the public
health.
``(2) The term `period of exclusivity', with respect to a
drug approved under section 505(c), means any period of
exclusivity under clause (ii), (iii), or (iv) of section
505(c)(3)(E), clause (ii), (iii), or (iv) of section
505(j)(5)(F), or section 505A, 505E, or 527.
``(3) The term `generic version' means a drug approved
under section 505(j) whose reference listed drug is a covered
drug.
``(4) The term `relevant accepted use' means a use for a
drug in clinical practice that is supported by scientific
evidence that appears to the Secretary to meet the standards
for approval under section 505.
``(5) The term `selected drug' means a covered drug for
which the Secretary has determined through the process under
subsection (c) that the labeling should be changed.
``(b) Identification of Covered Drugs.--The Secretary may
identify covered drugs for which labeling updates would
provide a public health benefit. To assist in identifying
covered drugs, the Secretary may do one or both of the
following:
``(1) Enter into cooperative agreements or contracts with
public or private entities to review the available scientific
evidence concerning such drugs.
``(2) Seek public input concerning such drugs, including
input on whether there is a relevant accepted use in clinical
practice that is not reflected in the approved labeling of
such drugs or whether new scientific evidence is available
regarding the conditions of use for such drug, by--
``(A) holding one or more public meetings;
``(B) opening a public docket for the submission of public
comments; or
``(C) other means, as the Secretary determines appropriate.
``(c) Selection of Drugs for Updating.--If the Secretary
determines, with respect to a covered drug, that the
available scientific evidence meets the standards under
section 505 for adding or modifying information to the
labeling or providing supplemental information to the
labeling regarding the use of the covered drug, the Secretary
may initiate the process under subsection (d).
``(d) Initiation of the Process of Updating.--If the
Secretary determines that labeling changes are appropriate
for a selected drug pursuant to subsection (c), the Secretary
shall provide notice to the holders of approved applications
for a generic version of such drug that--
``(1) summarizes the findings supporting the determination
of the Secretary that the available scientific evidence meets
the standards under section 505 for adding or modifying
information or providing supplemental information to the
labeling of the covered drug pursuant to subsection (c);
``(2) provides a clear statement regarding the additional,
modified, or supplemental information for such labeling,
according to the determination by the Secretary (including,
as applicable, modifications to add the relevant accepted use
to the labeling of the drug as an additional indication for
the drug); and
``(3) states whether the statement under paragraph (2)
applies to the selected drug as a class of covered drugs or
only to a specific drug product.
``(e) Response to Notification.--Within 30 days of receipt
of notification provided by the Secretary pursuant to
subsection (d), the holder of an approved application for a
generic version of the selected drug shall--
``(1) agree to change the approved labeling to reflect the
additional, modified, or supplemental information the
Secretary has determined to be appropriate; or
``(2) notify the Secretary that the holder of the approved
application does not believe that the requested labeling
changes are warranted and submit a statement detailing the
reasons why such changes are not warranted.
``(f) Review of Application Holder's Response.--
``(1) In general.--Upon receipt of the application holder's
response, the Secretary shall promptly review each statement
received under subsection (e)(2) and determine which labeling
changes pursuant to the Secretary's notice under subsection
(d) are appropriate, if any. If the Secretary disagrees with
the reasons why such labeling changes are not warranted, the
Secretary shall provide opportunity for discussions with the
application holders to reach agreement on whether the
labeling for the covered drug should be updated to reflect
available scientific evidence, and if so, the content of such
labeling changes.
``(2) Changes to labeling.--After considering all responses
from the holder of an approved application under paragraph
(1) or (2) of subsection (e), and any discussion under
paragraph (1), the Secretary may order such holder to make
the labeling changes the Secretary determines are
appropriate. Such holder of an approved application shall--
``(A) update its paper labeling for the drug at the next
printing of that labeling;
``(B) update any electronic labeling for the drug within 30
days of such order; and
``(C) submit the revised labeling through the form,
`Supplement--Changes Being Effected'.
``(g) Violation.--If the holder of an approved application
for the generic version of the selected drug does not comply
with the requirements of subsection (f)(2), such generic
version of the selected drug shall be deemed to be misbranded
under section 502.
``(h) Limitations; Generic Drugs.--
``(1) In general.--With respect to any labeling change
required under this section, the generic version shall be
deemed to have the same conditions of use and the same
labeling as its reference listed drug for purposes of clauses
(i) and (v) of section 505(j)(2)(A). Any labeling change so
required shall not have any legal effect for the applicant
that is different than the legal effect that would have
resulted if a supplemental application had been submitted and
approved to conform the labeling of the generic version to a
change in the labeling of the reference drug.
``(2) Supplemental applications.--Changes to labeling made
in accordance with this section shall not be eligible for an
exclusivity period under this Act.
``(3) Selection of drugs.--Nothing in this section shall be
construed to give the Secretary the authority to identify a
drug as a covered drug or select a drug label for updating
solely based on the availability of new safety information.
Upon identification of a drug as a covered drug, the
Secretary may then consider the availability of new,
additional, or different safety information in determining
whether the drug is a selected drug and in determining what
labeling changes are appropriate.
``(4) Maintenance of labeling.--Nothing in this section
shall be construed to affect the responsibility of the holder
of an approved application under section 505(j) to maintain
its labeling in accordance with existing requirements,
including subpart B of part 201 and sections 314.70 and
314.97 of title 21, Code of Federal Regulations (or any
successor regulations).
``(i) Rules of Construction.--
``(1) Approval standards.--This section shall not be
construed as altering the applicability of the standards for
approval of an application under section 505. No order shall
be issued under this subsection unless the scientific
evidence supporting the changed labeling meets the standards
for approval applicable to any change to labeling under
section 505.
``(2) Secretary authority.--Nothing in this section shall
be construed to limit the authority of the Secretary to
require labeling changes under section 505(o).
``(j) Reports.--Not later than 4 years after the date of
the enactment of the Making Objective Drug Evidence Revisions
for New Labeling Act of 2020, and every 4 years thereafter,
the Secretary shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate, a report that--
[[Page H5806]]
``(1) describes the actions of the Secretary under this
section, including--
``(A) the number of covered drugs and description of the
types of drugs the Secretary has selected for labeling
changes and the rationale for such recommended changes; and
``(B) the number of times the Secretary entered into
discussions concerning a disagreement with an application
holder or holders and a summary of the decision regarding a
labeling change, if any; and
``(2) includes any recommendations of the Secretary for
modifying the program under this section.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 5668.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 5668, the MODERN
Labeling Act.
Prescription drug labels contain the most authoritative drug-related
information available to prescribers. These labels let prescribers know
about approved uses for a drug and important patient safety
information.
However, over time, labels can become outdated as more information
becomes known about a drug, but a manufacturer may not update the label
with the Food and Drug Administration to identify new uses for drugs.
This is especially likely to happen with some older generic drugs where
there may be commonly accepted off-label uses but no FDA-sanctioned
method of communicating those safe uses.
In some cases, a generic drug may have an outdated label due to a
loophole in the law. Under this loophole, if a listed brand drug leaves
the market while a generic competitor remains, there is no way for the
generic drug to update its label with approved new uses. This is
because generic drugs must maintain the same drug information on their
labels as their branded counterparts, even when their branded
counterpart has left the market.
This bipartisan legislation, Mr. Speaker, would fix this problem.
H.R. 5668 would allow FDA to identify drugs that have out-of-date
labels and pursue revised labeling, allowing new uses and new
indications to be listed. This will allow FDA and generic drug
manufacturers to ensure that drug labels, the most trusted source of
drug use information, include the best information available.
Mr. Speaker, it is important to note that both brand and generic
manufacturers have the responsibility to work with FDA to update drug
safety information that becomes known and that does not change under
this bill.
Amendments adopted through our committee process ensure that, when a
manufacturer needs to update a label solely with new safety
information, manufacturers and FDA must pursue such changes through the
current process. Drug safety is paramount, and we want patients to have
certainty that they will have up-to-date safety information.
As Dr. Jeff Allen from the Friends of Cancer Research said at our
hearing on this bill: ``Preserving the accuracy and reliability of
labeling may be viewed as tantamount to preserving trust in and the
relevance of the drug approval system.''
And I cannot agree more, Mr. Speaker. Maintaining our trust in the
FDA approval process is critical, and this bill will help strengthen
the system.
Mr. Speaker, I urge all Members to support this bill, and I reserve
the balance of my time.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 5668. This is the MODERN
Labeling Act, and I want to thank our colleagues, Representatives
Guthrie and Matsui, for their leadership on this important legislation
which will allow the FDA to require modifications be made to outdated
labeling for generic drugs.
Now, while drug manufacturers are required to update a label when it
becomes inaccurate, false, or misleading, there is no such requirement
when new scientific information indicates there may be a new use for
the product.
Generic drugs are generally required to have the same labeling as the
brand drug they reference; however, once the brand drug is no longer on
the market, the generic manufacturer is actually prohibited from
updating their label to reflect the most accurate, up-to-date
information, information that is often discovered through postmarket
use. So the inability to update labeling can result in information gaps
for providers and patients when discussing treatments.
For example, it has been estimated that more than half, Mr. Speaker--
half--of all uses of cancer drugs are off-label, meaning the drug is
used for a disease or medical condition that it is not approved to
treat. Many of these uses are widely accepted in the medical community
and based on the most up-to-date scientific evidence; however, they are
not reflected in FDA-approved labeling.
So H.R. 5668 would help. It would close this existing information
gap. It would give doctors and patients the information they need when
making decisions about their treatment options.
Mr. Speaker, I urge support of this bill, and I reserve the balance
of my time.
Mr. PALLONE. Mr. Speaker, I believe we have a speaker on the other
side, so I continue to reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I yield 3 minutes to the gentleman from
Kentucky (Mr. Guthrie), one of our terrific leaders on the Energy and
Commerce Committee on the Republican side and someone who put a lot of
time and effort into this bipartisan legislation.
Mr. GUTHRIE. Mr. Speaker, I thank the ranking member for yielding.
I appreciate working with the chairman and with everyone involved in
this piece of legislation.
I rise today to voice my support for H.R. 5668, the MODERN Labeling
Act of 2020. This important bill will ensure that certain drug labels
are updated and accurate, which will result in better care for many
Americans who are suffering. This bill grants FDA the authority to work
with generic drug companies to update their product label when there
are strong, scientific bases for another indication or use of the drug.
Innovation in America is constantly evolving, and we must ensure drug
labels are updated and not frozen in time just because the brand-name
drug is off the market and preventing the generic drug from updating
its label.
I would like to thank Representative Matsui, Chairman Pallone, and
the majority and minority Energy and Commerce Committee staff who
worked with me to make this legislation possible.
I urge my colleagues to support this important bill.
Mr. PALLONE. Mr. Speaker, may I inquire if the gentleman has any
additional speakers.
Mr. WALDEN. Mr. Speaker, no, I do not.
I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, I ask all of our Members to support this
bill, and I yield back the balance of my time.
Ms. ESHOO. Mr. Speaker, I rise in support of H.R. 5668, the MODERN
Labeling Act. I'm proud to have advanced this bipartisan bill through
my Health Subcommittee and I'm proud to support it on the Floor today.
The MODERN Labeling Act was introduced by Representatives Doris
Matsui and Bret Guthrie, and allows generic drug companies to update
outdated labeling
Drug labeling can become outdated when new scientific evidence is
discovered after a drug is on the market, yet drug manufacturers are
not required by law to update their products' labeling with new uses.
Because of this system, the labeling of many cancer drugs, especially
older generic products, are out of date. Outdated labeling can affect
insurance and Medicare coverage of the drugs, creating potentially high
out-of-pocket costs for consumers.
H.R. 5668 addresses this problem by giving the FDA the authority to
require labels to reflect new information relevant to the drug and its
use.
This is a commonsense bill that will help more cancer patients have
access to the treatments they need and I urge all my colleagues to
support this legislation.
[[Page H5807]]
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 5668, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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